Increasingly, companies in the nutraceuticals sector are realizing that scientific validation of products is a necessary part of doing business that can pay off in the long-term.

According to Doug Kalman, PhD, RD, FACN, CCRC, director, Endocrinology & Nutrition Division, Applied Clinical Trials, at Miami Research Associates, Miami, FL, companies are paying much more attention to the food/supplement/nutrition market as it relates to scientific evaluation.

MRA conducts about 20 nutrition projects per year—compared to about five 13 years ago—ranging from proof-of-concept clinical trials to the gold standard randomized, double-blind, placebo-controlled trials, as well as new dietary ingredient (NDI) and Generally Recognized As Safe (GRAS) evaluations.

Established in 1996, MRA began conducting clinical trials primarily for the pharmaceutical and medical device industries, and over-the-counter (OTC) switches, noted Mr. Kalman. “I joined in 2000 and we expanded to include food, nutrition, dietary supplements and functional foods.”

Today, MRA’s state-of-the-art, 11,000-square-feet, 75-bed, Phase 1 Center offers sponsors the ability to conduct safe, reliable and efficient early phase studies in a controlled environment. The company is able to conduct complex clinical trials due to a highly trained clinical staff, multi-specialty physicians on-site and on-call, high investigator involvement, the ability to conduct trials from Phase I to IV, access to a diverse patient population and outstanding recruitment/retention capabilities.

An Uptick
“We’ve seen a large uptick in recent years of companies looking to first evaluate an ingredient to see if it has the utility they think it does,” said Mr. Kalman, “and then to conduct the clinical research” and establish intellectual property. “A lot of larger companies, worldwide, are looking to do clinical trials on ingredients that will satisfy the FDA as well as EFSA (European Food Safety Authority).”

Mr. Kalman went on to note an increased interest in clinical evaluation of functional food ingredients for gastrointestinal, neurological and cardiac uses. “We are seeing a larger role for supplements and food or food ingredients in those categories. It’s been quite interesting.”

Miami Research benefits from crossover within departments, he added. For example, “our nutrition department is doing studies with our gastroenterology department or with our neuroscience department or pediatrics department, looking at probiotics and skin health or eczema.”

“Within the past year or two the most active segment has been either food ingredients or dietary supplements or compounds that will be NDI or GRAS for mental health—both for mood states and for cognition,” he said.

The types of companies active in conducting and sponsoring research runs the gamut—from large companies like Abbott Laboratories and Nestle, which are heavily invested in medical nutrition, to pharmaceutical companies that are investing in the supplement/nutrition industry, like GlaxoSmithKline and others.

“It’s obvious to us based on the contracts that we get, that Big Pharma and Big Food is very interested in this area. They are the ones that obviously have more dollars behind them to pay for research, but they are also opening the door for other companies once they have product validation or NDIs.”

Costs Now vs. Later
Unfortunately, many companies only sponsor studies after they get hit with a lawsuit that suggests they don’t have substantiation for their marketing claims, or they are challenged by the National Advertising Division (NAD) of the Council of Better Business Bureaus, Mr. Kalman said.

“It probably cost them more money long-term in lawyer fees and study costs versus if they had done the study upfront as part of their marketing plan/budget,” said Mr. Kalman, who recommended that companies investigate how to get IRS tax credits for conducting their clinical work. “Many nutrition/dietary supplement companies don’t have good accounting/legal guidance and miss out that they could be sponsoring studies and it wouldn’t cost them the full value. There are research and development tax credits on the state and federal level.”